Guidewire for dilating eustachian tube via middle ear

ABSTRACT

A guidewire includes a guidewire shaft and an inflatable element arranged at a distal end of the guidewire shaft. At least a portion of the guidewire shaft is formed of metal, and the guidewire shaft includes a lumen that fluidly communicates with an interior of the inflatable element. The inflatable element is operable to transition between a deflated state in which the inflatable element is configured to pass through an isthmus of a Eustachian tube (ET), and an inflated state in which the inflatable element is configured to dilate the ET.

BACKGROUND

As shown in FIG. 1, the ear (10) is divided into three parts: anexternal ear (12), a middle ear (14) and an inner ear (16). The externalear (12) consists of an auricle (18) and ear canal (20) that gathersound and direct it toward a tympanic membrane (22) (also referred to asthe eardrum) located at an inner end (24) of the ear canal (20). Themiddle ear (14) lies between the external and inner ears (12, 16) and isconnected to the back of the throat by a Eustachian tube (ET) (26),which serves as a pressure equalizing valve between the ear (10) and thesinuses. The ET (26) terminates in a pharyngeal ostium (28) in thenasopharynx region (30) of the throat (32). In addition to the eardrum(22), the middle ear (14) also consists of three small ear bones(ossicles): the malleus (34) (hammer), incus (36) (anvil) and stapes(38) (stirrup).

The ET (26) is a narrow channel connecting the middle ear (14) with thenasopharynx (30). The ET (26) functions as a pressure equalizing valvefor the middle ear (14), which is normally filled with air. Whenfunctioning properly, the ET (26) opens for a fraction of a secondperiodically in response to swallowing or yawning. In so doing, itallows air into the middle ear (14) to replace air that has beenabsorbed by the middle ear lining (mucous membrane) or to equalizepressure changes occurring on altitude changes. Anything that interfereswith this periodic opening and closing of the ET (26) may result inhearing impairment or other ear symptoms. Obstruction or blockage of theET (26) results in a negative middle ear (14) pressure, with retraction(sucking in) of the eardrum (22). This may be accompanied by some eardiscomfort, such as a fullness or pressure feeling, and may result in amild hearing impairment and head noise (tinnitus). If the obstruction isprolonged, the middle ear (14) may eventually become infected.

Methods for treating the middle ear (14) and the ET (26) include thosedisclosed in U.S. Patent Pub. No. 2010/0274188, entitled “Method andSystem for Treating Target Tissue within the ET,” published on Oct. 28,2010, now abandoned, the disclosure of which is incorporated byreference herein; U.S. Patent Pub. No. 2013/0274715, entitled “Methodand System for Eustachian Tube Dilation,” published on Oct. 17, 2013,now abandoned, the disclosure of which is incorporated by referenceherein; and U.S. Patent Pub. No. 2015/0374963, entitled “Vent Cap for aEustachian Tube Dilation System,” published on Dec. 31, 2015, issued asU.S. Pat. No. 10,350,396 on Jul. 16, 2019, the disclosure of which isincorporated by reference herein. As described in those references,functioning of the ET (26) may be improved by dilating the ET (26) withan expandable dilator instrument.

While a variety of surgical instruments have been made and used, it isbelieved that no one prior to the inventors has made or used theinvention described in the appended claims.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated in and constitute apart of this specification, illustrate embodiments of the invention,and, together with the general description of the invention given above,and the detailed description of the embodiments given below, serve toexplain the principles of the present invention.

FIG. 1 depicts a cross-sectional view of a patient's head, showing theinner ear, the middle ear, the outer ear, and the Eustachian tubeconnecting the middle ear with the nasopharynx region of the throat;

FIG. 2A depicts a side elevational view of an exemplary guide catheter;

FIG. 2B depicts a cross-sectional view of the guide catheter of FIG. 2A,taken along line 2B-2B in FIG. 2A;

FIG. 3 depicts an enlarged elevational view of the distal end of theguide catheter of FIG. 2A;

FIG. 4A depicts a side elevational view of an exemplary balloon dilationcatheter that may be used with the guide catheter of FIG. 2A;

FIG. 4B depicts a cross-sectional view of the balloon dilation catheterof FIG. 4A, taken along line 4B-4B in FIG. 5;

FIG. 5 depicts an enlarged elevational view of the distal end of theballoon dilation catheter of FIG. 4A;

FIG. 6A depicts a cross-sectional view of a patient's head, showing theguide catheter of FIG. 2A, a guidewire, and an endoscope beingpositioned in relation to the patient's Eustachian tube via the throat;

FIG. 6B depicts a cross-sectional view of the patient's head of FIG. 6A,showing the balloon dilation catheter of FIG. 4A inserted into theEustachian tube and subsequently expanded to dilate the Eustachian tube;

FIG. 7 depicts a perspective view of an exemplary guidewire having aninflatable balloon and a navigation sensor;

FIG. 8 depicts a side elevational view of the guidewire of FIG. 7,showing an internal inflation lumen and a sensor wire of the guidewireschematically;

FIG. 9 depicts a cross-sectional view of the guidewire of FIG. 7, takenalong line 9-9 in FIG. 8;

FIG. 10 depicts a schematic perspective view of an exemplary surgicalnavigation system that incorporates the guidewire of FIG. 7;

FIG. 11A depicts a cross-sectional view of a patient's head, showing adistal portion of the guidewire of FIG. 7 positioned within thepatient's Eustachian tube via the middle ear;

FIG. 11B depicts a cross-sectional view of the patient's head of FIG.11A, showing the balloon of the guidewire inflated to thereby dilate theEustachian tube;

FIG. 12A depicts a schematic view of a tympanic membrane of the patientof FIG. 11A, viewing medially from the ear canal, before the step shownin FIG. 11A;

FIG. 12B depicts a schematic view of the tympanic membrane of FIG. 12A,showing tissue surrounding the tympanic membrane having been incised andthe tympanic membrane having been folded upwardly to provide access tothe middle ear, with the guidewire of FIG. 7 having been inserted intothe middle ear to perform the steps shown in FIGS. 11A-11B; and

FIG. 12C depicts a schematic view of the tympanic membrane of FIG. 12A,showing the tympanic membrane and surrounding tissue replaced to theiroriginal positions using a fixation method, after completion of thesteps shown in FIGS. 11A-11B.

The drawings are not intended to be limiting in any way, and it iscontemplated that various embodiments of the invention may be carriedout in a variety of other ways, including those not necessarily depictedin the drawings. The accompanying drawings incorporated in and forming apart of the specification illustrate several aspects of the presentinvention, and together with the description serve to explain theprinciples of the invention; it being understood, however, that thisinvention is not limited to the precise arrangements shown.

DETAILED DESCRIPTION

The following description of certain examples of the invention shouldnot be used to limit the scope of the present invention. Other examples,features, aspects, embodiments, and advantages of the invention willbecome apparent to those skilled in the art from the followingdescription, which is by way of illustration, one of the best modescontemplated for carrying out the invention. As will be realized, theinvention is capable of other different and obvious aspects, all withoutdeparting from the invention. Accordingly, the drawings and descriptionsshould be regarded as illustrative in nature and not restrictive.

For clarity of disclosure, the terms “proximal” and “distal” are definedherein relative to a surgeon, or other operator, grasping a surgicalinstrument having a distal surgical end effector. The term “proximal”refers to the position of an element arranged closer to the surgeon, andthe term “distal” refers to the position of an element arranged closerto the surgical end effector of the surgical instrument and further awayfrom the surgeon. Moreover, to the extent that spatial terms such as“upper,” “lower,” “vertical,” “horizontal,” or the like are used hereinwith reference to the drawings, it will be appreciated that such termsare used for exemplary description purposes only and are not intended tobe limiting or absolute. In that regard, it will be understood thatsurgical instruments such as those disclosed herein may be used in avariety of orientations and positions not limited to those shown anddescribed herein.

As used herein, the terms “about” and “approximately” for any numericalvalues or ranges indicate a suitable dimensional tolerance that allowsthe part or collection of components to function for its intendedpurpose as described herein.

I. Exemplary Eustachian Tube Dilation Catheter System

One example of a treatment that may be performed to treat an ET (26)that does not provide sufficient communication between the middle ear(14) and the pharyngeal ostium (28) includes accessing and dilating theET (26) using a guide catheter (100) and a balloon dilation catheter(200), examples of which are shown in FIGS. 2A-5. Guide catheter (100)of the present example includes an elongate tubular shaft (102) that hasa proximal end (104), a distal end (106) and a lumen (108) therebetween.As shown in FIG. 2B, shaft (102) has an outer shaft tube (110), an innershaft tube (112) and a lumen (108). As shown in FIG. 3, the distalportion (120) of the guide catheter (100) has a bend (122) thatfacilitates access into the ET (26) via the pharyngeal ostium (28). Thedistal tip (124) of the distal portion (120) of the guide catheter (100)provides for atraumatic access to the ET (26). As shown in FIG. 2A, theproximal portion (130) of guide catheter (100) includes a proximal hub(132) to aid in insertion of balloon catheter (200) into the ET (26).The hub (132) has a larger diameter proximal end (134) and a smallerdiameter middle section (136).

As shown in FIG. 4A, balloon dilation catheter (200) of the presentexample generally includes an elongate shaft (202) having a proximal end(214) and a distal end (218). Balloon dilation catheter (200) furtherincludes a balloon (204) longitudinally fixed at the distal end (218) ofthe elongate shaft (202). In some versions, the balloon (204) comprisesa suitable non-compliant material. The balloon dilation catheter (200)generally includes a proximally located connection (230) forinflating/activating the balloon (204) by communicating a pressurizedmedium (e.g., saline) to balloon (204).

Balloon (204) may be expanded to dilate the ET (26) after balloon (204)is placed in a desirable location in the ET (26). For example, dilationcatheter (200) may be advanced to position the balloon (204) in thepharyngeal ostium (28) as shown in FIG. 6A. An endoscope (60) may beused to assist in positioning the dilation catheter (200). A marker(208) on a shaft of the dilation catheter (200) can be viewed fromendoscope (60) to approximate a location of the balloon (204) relativeto the opening of the ET (26) (e.g., pharyngeal ostium (28)) based on adistance of the marker (208) from a proximal end of the balloon (204).

Balloon dilation catheter (200) further includes an actuator (210).Actuator (210) has a proximal side (220) and a distal side (222). Theportion (240) of elongate shaft (202) that is distal of actuator (210)is sufficiently stiff to be guided through the nasal cavity and into theET (26). The portion (238) of elongate shaft (202) that is proximal ofactuator (210) and the portion (250) that is distal to portion (240) ismore flexible than the portion (240). The distal end (218) of ballooncatheter (200) further includes a tip (212) and a flexible shaft portion(250) that extends from the distal end of the elongate shaft (202) tothe proximal end of balloon (204). In the example shown in FIG. 4A, tip(212) is a bulbous polymeric blueberry-shaped, atraumatic tip.

After balloon (204) is positioned within the ET (26) and inflated to anexpanded state (e.g., as shown in FIG. 6B), balloon (204) may be held inlocation while in an expanded state for an extended period of time (e.g.several seconds or minutes). The balloon catheter (200) may also delivera substance to the ET (26), such as one or more of the therapeutic ordiagnostic agents described herein. Balloon (204) may also carry anexpandable stent for delivery into the ET (26) upon expansion of balloon(204). Balloon dilation catheter (200) and guide catheter (100) may beremoved from the patient after balloon (204) has beendeflated/unexpanded. The ET (26) will resume functioning, normallyopening and closing to equalize atmospheric pressure in the middle ear(14) and protect the middle ear (14) from unwanted pressure fluctuationsand loud sounds.

II. Exemplary Instrument for Dilating Eustachian Tube Via Middle Ear,and Related Surgical Navigation System

In some instances, it may be difficult or impossible to access the ET(26) by inserting instruments through the nostril, into the oro-nasalcavity, and through the pharyngeal ostium, as shown in FIGS. 6A-6Bdescribed above. This may be due to the anatomical constraints of apatient or, in some instances, to the limitations of a particularpractitioner's skill set. Therefore, in some instances, it may be moreefficacious to access the ET (26) through the tympanic membrane (22) andthe middle ear (14). However, due to the sensitive nature of thetympanic membrane (22) and middle ear structures, it may be advantageousto access the ET (26) in a manner that preserves the integrity of the ET(26) or minimizes trauma to the ET (26). Moreover, because this approachof accessing the ET (26) requires a practitioner to direct instrumentsthrough the isthmus (29), care must be taken due to the small size andsensitive nature of the isthmus (29) and adjacent structures of theinner ear (16).

The exemplary alternative dilation instrument (300) described belowenables a practitioner to safely access the ET (26) via the middle ear(14) while still being operable to provide sufficient dilation of the ET(26) once positioned.

A. Exemplary Guidewire Having Inflatable Balloon

FIG. 7 shows an exemplary guidewire (300) that is sized and configuredto access the ET (26) through the tympanic membrane (22), the middle ear(14), and the isthmus (29), and which may be used in place of guidewire(80) and balloon dilation catheter (200) described above. Guidewire(300) includes an elongate shaft (302) having a distal end (304), and aclosed atraumatic tip (306) arranged at distal end (304). Atraumatic tip(306) of the present example is generally rounded in shape and issuitably sized to pass through the isthmus (29) and into the ET (26), asdescribed in greater detail below.

Guidewire shaft (302) of the present example is suitably constructedwith a lateral flexibility and a column strength (i.e., stiffness)sufficient to enable guidewire (300) to resiliently conform to thetortuous internal path extending between the middle ear (14) and the ET(26) of a patient without buckling or otherwise plastically deforming,and without an outer guidance device such as guide catheter (100). Forinstance, at least a portion of shaft (302) may be formed of braidedstainless steel. In other examples, at least a portion of shaft (302)may be constructed with an outer coil and an inner core-wire. In variousexamples, guidewire shaft (302) may be formed of one or more metalmaterials such as 316 stainless steel, titanium, cobalt-chrome, nitinol,MP35N steel alloy, or various other suitable materials as disclosed inU.S. Pat. Pub. No. 2016/0008083, entitled “Guidewire Navigation forSinuplasty,” published Jan. 14, 2016, issued as U.S. Pat. No. 10,463,242on Nov. 5, 2019, the disclosure of which is incorporated by referenceherein.

Guidewire (300) of the present example further includes an expandableelement in the form of an inflatable balloon (308) secured to anexterior of guidewire shaft (302) proximal to distal tip (306). Balloon(308) may be compliant, semi-compliant, or non-compliant inconstruction, and may be formed of any suitable polymeric material suchas polyethylene terepthalate (PET), PEBAX® (polyether block amide),nylon, or the like. Balloon (308) of the present example is suitablysized and configured to provide guidewire (300) with a maximum outerdiameter of less than or equal to approximately 1 millimeter whenballoon (308) is deflated, as shown in FIG. 11A, and a maximum outerdiameter of approximately 6 millimeters or greater when balloon (308) isfully inflated, as shown in FIGS. 7-9 and 11B. In at least someapplications, a maximum outer diameter of approximately 6 millimetersprovides sufficient dilation of a patient's ET (26) during an ETdilation procedure. It will be appreciated, however, that balloon (308)may be suitably configured to assume other maximum sizes for use inother applications and dilation procedures. Balloon (308) of the presentexample may have a working length of approximately 12 millimeters toapproximately 24 millimeters. In other examples, balloon (308) may havea working length of approximately 20 millimeters to approximately 40millimeters.

As shown best in FIGS. 8 and 9, an internal inflation lumen (310)extends longitudinally through guidewire shaft (302) along the centrallongitudinal axis of shaft (302). A proximal end of inflation lumen(310) fluidly communicates with an inflation medium source (not shown).A distal end of inflation lumen (310) fluidly communicates with aninterior of balloon (308) via a plurality of apertures (312) that extendlaterally through the sidewall of guidewire shaft (302). While guidewireshaft (302) of the present example includes four apertures (312)approximately aligned with a medial portion of balloon (308), anysuitable quantity and arrangement of apertures (312) may be provided inother examples. As seen in FIG. 8, inflation lumen (310) terminates at adistal wall (314) located distal to the distal-most aperture (312) andproximal to a distal end of balloon (308). Inflation lumen (310) isconfigured to communicate a pressurized medium (e.g., saline) to andfrom the interior of balloon (308) in response to user input to enableselective inflation and deflation during a dilation procedure, forexample as described below in connection with FIGS. 11A-11C.

Though not shown, guidewire (300) may be actuated with an actuatingdevice of any suitable type that may be held and operated by a user, andwhich may have features similar to those disclosed in U.S. patentapplication Ser. No. 15/840,346, entitled “Dilation Instrument withProximally Located Force Sensor,” filed Dec. 13, 2017, published as U.S.Pub. No. 2019/0175887 on Jun. 13, 2019, the disclosure of which isincorporated by reference herein.

As shown best in FIGS. 7 and 8, guidewire (300) of the present examplefurther includes a navigation sensor (316) (shown schematically)arranged at distal end (304) proximal to distal tip (306) and distal tothe distal end of balloon (308). Navigation sensor (316) is operable togenerate signals corresponding to the location of distal end (304)within a patient during a surgical procedure, and thus enables a surgeonto track the location of distal end (304) within the patient in realtime, as described in greater detail below. Navigation sensor (316) maybe in the form of an electrically conductive coil configured to generatean electrical signal when placed within an externally generated magneticfield, as described below.

As shown in FIGS. 8 and 9, guidewire (300) houses a pair of sensor wires(318) that couple to navigation sensor (316) and extend proximallythrough distal lumen wall (314) and inflation lumen (310) toward aproximal end of guidewire (300). The location at which sensor wires(318) extend through distal lumen wall (314) may be sealed with anadhesive (320) or other material suitable to prevent ingress ofinflation fluid from lumen (310) toward navigation sensor (316).Accordingly, navigation sensor (316) is fluidically isolated frominflation lumen (310). Sensor wires (318) are configured to communicateelectrical signals from navigation sensor (316) to the processor of anavigation system, such as processor (408) of surgical navigation system(400) described below. While only one navigation sensor (316) is shown,two or more navigation sensors may be provided in other examples atvarious locations within guidewire (300), for instance to track both alocation and a rotational orientation of distal end (304) of guidewire(300) within the patient. It will be appreciated, however, thatnavigation sensor (316) is merely optional and may be entirely omittedfrom guidewire (300) in some examples. In such examples, guidewire (300)may be navigated through the anatomical passages of a patient with theassistance of various other suitable guidance devices and methodsreadily apparent to those skilled in the art, or without any suchguidance devices.

B. Exemplary Surgical Navigation System Incorporating Guidewire

Image-guided surgery (IGS) is a technique in which a computer is used toobtain a real-time correlation of the location of an instrument that hasbeen inserted into a patient's body to a set of preoperatively obtainedimages. In some IGS procedures, a digital tomographic scan (e.g., CT orMRI, 3-D map, etc.) of the operative field is obtained prior to surgeryand converted into a digital map. Instruments having sensors mountedthereon are used to perform a surgical procedure while the sensors senddata to the computer indicating the current position of each surgicalinstrument. The computer correlates the data it receives from theinstrument-mounted sensors with the digital map. The tomographic scanimages are displayed on a system display device (e.g., a video monitor)along with an indicator (e.g., cross hairs or an illuminated dot, etc.)showing the real-time position of each surgical instrument relative tothe anatomical features shown in the scan images.

FIG. 10 shows an exemplary IGS navigation system (400) that incorporatesguidewire (300) described above. Surgical navigation system (400) isconfigured to implement navigation sensor (316) of guidewire (300) toprovide real-time location tracking of distal end (304) of guidewire(300) within a patient (P) during a surgical procedure. Surgicalnavigation system (400) includes a field generator assembly (402), whichcomprises a set of magnetic field generators (406) that are supported bya U-shaped frame (404) configured to be positioned about the head (H) ofpatient (P). Field generators (406) are operable to generate alternatingmagnetic fields of different frequencies around the patient's head (H).In the present example, frame (404) is mounted to the headrest of achair (430), with patient (P) being seated in chair (430) such thatframe (404) partially surrounds the patient's head (H). By way ofexample only, chair (430) and/or field generator assembly (102) may beconfigured and operable in accordance with at least some of theteachings of U.S. patent application Ser. No. 15/933,737, entitled“Apparatus to Secure Field Generating Device to Chair,” filed Mar. 23,2018, issued as U.S. Pat. No. 10,561,370 on Feb. 18, 2020, thedisclosure of which is incorporated by reference herein.

Navigation sensor (316) is provided in the form of one or moreelectrically conductive coils in the present example. The presence ofnavigation sensor (316) in the alternating magnetic generated by fieldgenerators (406) field induces an electrical current in sensor (316),which is communicated as an electric signal proximally through sensorwires (318) to a processor (408) of surgical navigation system (400).Processor (408) receives the signals and executes an algorithm todetermine a location of navigation sensor (316) within athree-dimensional space occupied by the alternating electromagneticfield, which surrounds head (H) of patient (P) in the present example.Processor (408) correlates this three-dimensional space to the knownanatomy of patient (P), analyzed preoperatively, and determines thethree-dimensional location of sensor (316) with patient (P).

Processor (408) of surgical navigation system (400) comprises aprocessing unit that communicates with one or more memories and isconfigured to control field generators (406) and other elements ofnavigation system (400). In the present example, processor (408) ismounted in a console (410), which comprises operating controls (412)that include a keypad and/or a pointing device such as a mouse ortrackball. A physician uses operating controls (412) to interact withprocessor (408) while performing the surgical procedure. Processor (408)uses software stored in a memory of processor (408) to calibrate andoperate system (400). Such operation includes driving field generators(406), processing data received from navigation sensor (316), processingdata from operating controls (412), and driving a display (414).

Guidewire navigation sensor (316) of the present example communicateswith system processor (408) via a communication unit (416) that iscoupled with a proximal end of guidewire (300), as shown schematicallyin FIG. 10, and connects with the proximal ends of sensor wires (318).Communication unit (416) is configured to provide wireless communicationof data and other signals between console (410) and navigation sensor(316). Alternatively, some other versions may provide wired couplingbetween communication unit (416) and console (410).

System display (414) is operable to depict a navigation image (418) thatshows the real-time position of distal end (304) of guidewire (300) inrelation to anatomy of patient (P). The anatomy may be presented bynavigation image (418) in the form of a video camera image, a CT scanimage, and/or a computer generated three-dimensional model of theanatomy, which may be displayed simultaneously and/or superimposed oneach other, for instance. In addition to the anatomy image, navigationimage (418) shows a graphical representation of guidewire (300). Thisgraphical representation is superimposed on the anatomy image andenables the physician to identify the position of distal end (304) ofguidewire (300) relative to adjacent anatomical features of patient (P)in real-time during a surgical procedure. By way of example only,display (414) may depict navigation image (418) in accordance with atleast some of the teachings of U.S. Pat. Pub. No. 2016/0008083, issuedas U.S. Pat. No. 10,463,242 on Nov. 5, 2019, entitled “GuidewireNavigation for Sinuplasty,” incorporated by reference above.

The IGS components of surgical navigation system (400) may be furtherconfigured in accordance with one or more teachings of U.S. Pat. No.7,720,521, entitled “Methods and Devices for Performing Procedureswithin the Ear, Nose, Throat and Paranasal Sinuses,” issued May 18,2010, the disclosure of which is incorporated by reference herein; U.S.Pat. Pub. No. 2016/0310042, entitled “System and Method to MapStructures of Nasal Cavity,” published Oct. 27, 2016, issued as U.S.Pat. No. 10,362,965 on Jul. 30, 2019, the disclosure of which isincorporated by reference herein; and U.S. Pat. Pub. No. 2014/0364725,entitled “Systems and Methods for Performing Image Guided Procedureswithin the Ear, Nose, Throat and Paranasal Sinuses,” published Dec. 11,2014, now abandoned, the disclosure of which is incorporated byreference herein.

C. Exemplary Method of Dilating Eustachian Tube Using Guidewire

FIGS. 11A-12C show an exemplary method of dilating the ET (26) of apatient using guidewire (300) described above. Rather than insertingguidewire (300) through a nostril, into the nasal cavity, and throughthe pharyngeal ostium (28), the method shown in FIGS. 11A-12C includesaccessing the ET (26) through the ear canal (20) and the tympanicmembrane (22). In the present example, guidewire (300) is advancedthrough ear canal (20) and navigated through the internal passageways ofthe patient's head with real-time guidance provided by navigation sensor(316) and IGS navigation system (400) as described above. As alsodescribed above, however, navigation sensor (316) is merely optional.Accordingly, in other examples, guidewire (300) may be employed toaccess and dilate the ET (26) with alternative types of guidancefeatures, such as an endoscope or an illuminating fiber (not shown); orwithout any such guidance features.

Those of ordinary skill in the art will recognize that the tympanicmembrane (22) provides a physical barrier to passage of an instrumentsuch as balloon catheter (400) from the ear canal (20) into the ET (26).Thus, an operator must somehow address the presence of the tympanicmembrane (22) in order to gain access to the ET (26) from the ear canal(20). The following description provides a merely illustrative methodfor handling the tympanic membrane (22) in order to suitably insertguidewire (300) into the ET (26) via the ear canal (20). Otherillustrative methods are disclosed in U.S. Pat. Pub. No. 2017/0119583,entitled “System and Method for Treatment of Eustachian Tube from MiddleEar Approach,” published on May 4, 2017, issued as U.S. Pat. No.10,070,993 on Sep. 11, 2018, the disclose of which is incorporated byreference herein.

In the example shown in FIGS. 11A-12C, the operator accesses the middleear (14) and ET (26) without compromising the integrity of the tympanicmembrane (22). As shown in FIG. 12A, the operator makes an incisionalong line (502) in the tissue surrounding tympanic membrane (22) butdoes not cut any part of tympanic membrane (22) itself. In the presentexample, cut line (502) is made adjacent to an inferior aspect of thetympanic membrane (22), along approximately half the perimeter of thetympanic membrane (22). Cut line (502) may be formed using any suitableconventional instrumentation. In other variations, cut line (502) may bemade such that it extends along a different portion of the tympanicmembrane (22) and may include a different length or shape than thatshown. Other suitable positioning and configurations of cut line (502)that may be made in order to create a sufficient opening (504) foraccess to the middle ear (14) and ET (26) will be apparent to personsskilled in the art in view of the teachings herein. As shown in FIGS.11A-11B and 12B, cut line (502) forms a flap (506) that may be foldedsuperiorly such that an opening (504) is created that provides access tothe middle ear (14) and ET (26). Alternatively, flap (506) may be foldedin a different manner or direction in order to create an opening withaccess to the middle ear (14) and ET (26).

As shown in FIG. 12B, the operator fixes flap (506) to a superiorportion of the ear canal (20) using a suture (508). To protect theintegrity of the tympanic membrane (22), the operator does not punctureor otherwise compromise the tympanic membrane (22) with a needle whenimplanting suture (508) on flap (506). In some other examples, theoperator may affix the flap (506) in a folded configuration in adifferent manner, such as by adhesive, or in any other suitable manneras will be apparent to persons skilled in the art in view of theteachings herein.

As shown in FIG. 11A, once a sufficient opening (504) is created, theoperator may direct a distal end portion of guidewire (300) into the earcanal (20), through opening (504), through the middle ear (14), past theisthmus (29), and into the ET (26). Throughout insertion into the ET(26), balloon (308) is in its deflated state in which it providesguidewire (300) with a maximum outer diameter of approximately 1millimeter or less as described above, to thereby minimize disruption toisthmus (29) and adjacent components of inner ear (16). As describedabove, guidewire shaft (302) is formed with a suitably rigidconstruction such that guidewire (300) may be advanced through theinternal passages of the patient without an external guidance device andwithout buckling.

As shown in FIG. 11B, once balloon (308) is suitably positioned withinthe ET (26), the operator inflates balloon (308) to thereby dilate theET (26). As described above, balloon (308) may be configured to provideguidewire (300) with a maximum outer diameter of approximately 6millimeters or more when inflated to provide a desired degree of ETdilation. Once inflated, balloon (308) may then be held in place withinthe ET (26) for an extended period of time (e.g. several seconds orminutes). In some instances, the operator may wish to repeatedly inflateand deflate balloon (308) within the ET (26) to achieve a desireddilation effect. Additionally, in some examples balloon (308) may beconfigured to carry an expandable stent for delivery into the ET (26)upon expansion of balloon (308). Once the ET (26) has been suitablydilated, balloon (308) may be guidewire (300) may be withdrawn from theET (26) by reversing the insertion steps described above.

Following removal of balloon guidewire (300), the ET (26) is leftdilated and able to resume normal functioning. Also following removal ofguidewire (300) from the patient, the operator may replace flap (506) asgenerally shown in FIG. 12C. In the present example, the operatorsevers, decouples, or otherwise removes suture (508) and causes flap(506) to return to the inferior position adjacent to cut line (502).Then, the operator couples the flap (506) with the tissue adjacent tocut line (502), for example with an adhesive. Suitable surgicaladhesives will be apparent to persons skilled in the art in view of theteachings herein. In other examples, the operator may couple the flap(506) to the tissue adjacent to cut line (502) in some other fashion,such as via suturing. Other suitable techniques that may be used tocouple the flap (506) to the tissue adjacent to cut line (502) will beapparent to persons skilled in the art in view of the teachings herein.

III. Exemplary Combinations

The following examples relate to various non-exhaustive ways in whichthe teachings herein may be combined or applied. It should be understoodthat the following examples are not intended to restrict the coverage ofany claims that may be presented at any time in this application or insubsequent filings of this application. No disclaimer is intended. Thefollowing examples are being provided for nothing more than merelyillustrative purposes. It is contemplated that the various teachingsherein may be arranged and applied in numerous other ways. It is alsocontemplated that some variations may omit certain features referred toin the below examples. Therefore, none of the aspects or featuresreferred to below should be deemed critical unless otherwise explicitlyindicated as such at a later date by the inventors or by a successor ininterest to the inventors. If any claims are presented in thisapplication or in subsequent filings related to this application thatinclude additional features beyond those referred to below, thoseadditional features shall not be presumed to have been added for anyreason relating to patentability.

EXAMPLE 1

A guidewire comprising: (a) a guidewire shaft, wherein at least aportion of the guidewire shaft is comprised of metal, wherein theguidewire shaft includes a lumen; and (b) an inflatable element arrangedat a distal end of the guidewire shaft, wherein an interior of theinflatable element fluidly communicates with the lumen, wherein theinflatable element is operable to transition between a deflated state inwhich the inflatable element is configured to pass through an isthmus ofa Eustachian tube (ET), and an inflated state in which the inflatableelement is configured to dilate the ET.

EXAMPLE 2

The guidewire of Example 1, wherein at least a portion of the guidewireshaft is comprised of braided stainless steel.

EXAMPLE 3

The guidewire of any of the previous Examples, wherein the lumen extendsalong a central axis of the guidewire shaft.

EXAMPLE 4

The guidewire of any of the previous Examples, further comprising aclosed distal tip.

EXAMPLE 5

The guidewire of any of Example 4, wherein the closed distal tip issized and configured to pass through the isthmus of the ET.

EXAMPLE 6

The guidewire of any of the previous Examples, wherein the inflatableelement comprises a balloon.

EXAMPLE 7

The guidewire of any of the previous Examples, wherein the guidewire isconfigured to assume a maximum outer diameter of 1 millimeter or lesswhen the inflatable element is in the deflated state.

EXAMPLE 8

The guidewire of any of the previous Examples, wherein the inflatableelement is configured to provide the guidewire with a maximum outerdiameter of at least 6 millimeters when the inflatable element is in theinflated state.

EXAMPLE 9

The guidewire of any of the previous Examples, further comprising anavigation sensor operable to generate a signal corresponding to alocation of a distal end of the guidewire within a patient.

EXAMPLE 10

The guidewire of Example 9, wherein the navigation sensor comprises anelectromagnetic sensor.

EXAMPLE 11

The guidewire of any of Examples 9 through 10, wherein theelectromagnetic sensor comprises an electrically conductive coil.

EXAMPLE 12

The guidewire of any of Examples 9 through 11, wherein the navigationsensor is arranged distal to the inflatable element.

EXAMPLE 13

The guidewire of any Examples 9 through 12, wherein the navigationsensor is isolated from the lumen.

EXAMPLE 14

The guidewire of any of Examples 9 through 13, wherein the lumenterminates at a distal wall, wherein the navigation sensor is locateddistal to the distal wall, wherein the guidewire further comprises asensor wire that extends through the lumen and the distal wall and iscoupled to the navigation sensor, wherein the sensor wire is configuredto communicate the signal generated by the navigation sensor.

EXAMPLE 15

A surgical navigation system comprising: (a) the guidewire of any ofExamples 9 through 14; and (b) a processor in communication with thenavigation sensor, wherein the processor is operable to receive andanalyze the signal generated by the navigation sensor to determine thelocation of the distal end of the guidewire within the patient.

EXAMPLE 16

A guidewire comprising: (a) a guidewire shaft, wherein the guidewireshaft includes a lumen; (b) an inflatable element arranged at a distalportion of the guidewire shaft, wherein an interior of the inflatableelement fluidly communicates with the lumen, wherein the inflatableelement is operable to transition between a deflated state in which theinflatable element is configured to pass through an isthmus of aEustachian tube (ET), and an inflated state in which the inflatableelement is configured to dilate the ET; and (c) a navigation sensor,wherein the navigation sensor is operable to generate a signalcorresponding to a location of a distal end of the guidewire within apatient.

EXAMPLE 17

The guidewire of Example 16, wherein the navigation sensor comprises anelectrically conductive coil.

EXAMPLE 18

The guidewire of any of Examples 16 through 17, wherein the navigationsensor is arranged distal to a proximal end of the inflatable element.

EXAMPLE 19

A guidewire comprising: (a) a guidewire shaft, wherein at least aportion of the guidewire shaft is comprised of metal; and (b) anexpandable element arranged at a distal portion of the guidewire shaft,wherein the expandable element is operable to transition between anunexpanded state in which the expandable element is configured to passthrough an isthmus of a Eustachian tube (ET), and an expanded state inwhich the expandable element is configured to dilate the ET, wherein theguidewire is configured to assume a maximum outer diameter of 1millimeter or less when the expandable element is in the unexpandedstate.

EXAMPLE 20

The guidewire of Example 19, wherein the expandable element isconfigured to provide the guidewire with a maximum outer diameter of atleast 6 millimeters when the expandable element is in the expandedstate.

IV. Miscellaneous

It should be understood that any one or more of the teachings,expressions, embodiments, examples, etc. described herein may becombined with any one or more of the other teachings, expressions,embodiments, examples, etc. that are described herein. Theabove-described teachings, expressions, embodiments, examples, etc.should therefore not be viewed in isolation relative to each other.Various suitable ways in which the teachings herein may be combined willbe readily apparent to those skilled in the art in view of the teachingsherein. Such modifications and variations are intended to be includedwithin the scope of the claims.

It should be appreciated that any patent, publication, or otherdisclosure material, in whole or in part, that is said to beincorporated by reference herein is incorporated herein only to theextent that the incorporated material does not conflict with existingdefinitions, statements, or other disclosure material set forth in thisdisclosure. As such, and to the extent necessary, the disclosure asexplicitly set forth herein supersedes any conflicting materialincorporated herein by reference. Any material, or portion thereof, thatis said to be incorporated by reference herein, but which conflicts withexisting definitions, statements, or other disclosure material set forthherein will only be incorporated to the extent that no conflict arisesbetween that incorporated material and the existing disclosure material.

Versions of the devices described above may have application inconventional medical treatments and procedures conducted by a medicalprofessional, as well as application in robotic-assisted medicaltreatments and procedures. By way of example only, various teachingsherein may be readily incorporated into a robotic surgical system suchas the DAVINCI™ system by Intuitive Surgical, Inc., of Sunnyvale, Calif.

Versions of the devices described above may be designed to be disposedof after a single use, or they can be designed to be used multipletimes. Versions may, in either or both cases, be reconditioned for reuseafter at least one use. Reconditioning may include any combination ofthe steps of disassembly of the device, followed by cleaning orreplacement of particular pieces, and subsequent reassembly. Inparticular, some versions of the device may be disassembled, and anynumber of the particular pieces or parts of the device may beselectively replaced or removed in any combination. Upon cleaning and/orreplacement of particular parts, some versions of the device may bereassembled for subsequent use either at a reconditioning facility, orby a user immediately prior to a procedure. Those skilled in the artwill appreciate that reconditioning of a device may utilize a variety oftechniques for disassembly, cleaning/replacement, and reassembly. Use ofsuch techniques, and the resulting reconditioned device, are all withinthe scope of the present application.

By way of example only, versions described herein may be sterilizedbefore and/or after a procedure. In one sterilization technique, thedevice is placed in a closed and sealed container, such as a plastic orTYVEK bag. The container and device may then be placed in a field ofradiation that can penetrate the container, such as gamma radiation,x-rays, or high-energy electrons. The radiation may kill bacteria on thedevice and in the container. The sterilized device may then be stored inthe sterile container for later use. A device may also be sterilizedusing any other technique known in the art, including but not limited tobeta or gamma radiation, ethylene oxide, or steam.

Having shown and described various embodiments of the present invention,further adaptations of the methods and systems described herein may beaccomplished by appropriate modifications by one of ordinary skill inthe art without departing from the scope of the present invention.Several of such potential modifications have been mentioned, and otherswill be apparent to those skilled in the art. For instance, theexamples, embodiments, geometrics, materials, dimensions, ratios, steps,and the like discussed above are illustrative and are not required.Accordingly, the scope of the present invention should be considered interms of the following claims and is understood not to be limited to thedetails of structure and operation shown and described in thespecification and drawings.

We claim:
 1. A guidewire comprising: (a) a guidewire shaft, wherein at least a portion of the guidewire shaft is comprised of metal, wherein the guidewire shaft includes a lumen; (b) a non-compliant balloon arranged at a distal end of the guidewire shaft, wherein an interior of the non-compliant balloon fluidly communicates with the lumen, wherein the non-compliant balloon is operable to transition between a deflated state in which the non-compliant balloon is configured to pass through an isthmus of a Eustachian tube (ET), and an inflated state in which the non-compliant balloon is configured to dilate the ET, wherein the guidewire is configured to assume a maximum outer diameter of 1 millimeter or less when the non-compliant balloon is in the deflated state, wherein the non-compliant balloon has a maximum outer diameter of at least 6 millimeters when the non-compliant balloon is in the inflated state to dilate the ET; (c) a navigation sensor operable to generate a signal corresponding to a location of a distal end of the guidewire within a patient; and (d) a sensor wire operatively coupled with the navigation sensor, wherein the sensor wire is fixably attached to an inner surface of the guidewire shaft within the inflatable element.
 2. The guidewire of claim 1, wherein at least a portion of the guidewire shaft is comprised of braided stainless steel.
 3. The guidewire of claim 1, wherein the lumen extends along a central axis of the guidewire shaft.
 4. The guidewire of claim 1, wherein the navigation sensor comprises an electromagnetic sensor.
 5. The guidewire of claim 4, wherein the electromagnetic sensor comprises an electrically conductive coil.
 6. The guidewire of claim 1, wherein the navigation sensor is arranged distal to the non-compliant balloon.
 7. The guidewire of claim 1, wherein the navigation sensor is isolated from the lumen.
 8. The guidewire of claim 1, wherein the lumen terminates at a distal wall, wherein the navigation sensor is located distal to the distal wall, wherein the sensor wire extends through the lumen and the distal wall and is coupled to the navigation sensor, wherein the sensor wire is configured to communicate the signal generated by the navigation sensor.
 9. The guidewire of claim 1, wherein the elongate shaft includes a plurality of apertures that are configured to fluidly communicate the lumen with the interior of non-compliant balloon, wherein the apertures are aligned with a medial portion of the non-compliant balloon.
 10. The guidewire of claim 1, wherein the ratio of the maximum outer diameter in the inflated state relative to the maximum outer diameter in the deflated state is at least 6:1.
 11. A surgical navigation system comprising: (a) the guidewire of claim 1; and (b) a processor in communication with the navigation sensor, wherein the processor is operable to receive and analyze the signal generated by the navigation sensor to determine the location of the distal end of the guidewire within the patient.
 12. A guidewire comprising: (a) a guidewire shaft that defines a longitudinal axis, wherein the guidewire shaft includes a lumen; (b) an inflatable element arranged at a distal portion of the guidewire shaft, wherein an interior of the inflatable element fluidly communicates with the lumen, wherein the inflatable element is operable to transition between a deflated state in which the inflatable element is configured to pass through an isthmus of a Eustachian tube (ET), and an inflated state in which the inflatable element is configured to dilate the ET; (c) a navigation sensor, wherein the navigation sensor is operable to generate a signal corresponding to a location of a distal end of the guidewire within a patient; and (d) a sensor wire that extends along the longitudinal axis through the entire inflatable element, wherein the sensor wire is fixably attached with an inner surface of the guidewire shaft within the inflatable element.
 13. The guidewire of claim 12, wherein the navigation sensor comprises an electrically conductive coil.
 14. The guidewire of claim 12, wherein the navigation sensor is arranged distal to a proximal end of the inflatable element.
 15. The guidewire of claim 12, wherein the inflatable element includes a non-compliant balloon, wherein the guidewire is configured to assume a maximum outer diameter of 1 millimeter or less when the non-compliant balloon is in the deflated state, wherein the non-compliant balloon is configured to provide the guidewire with a maximum outer diameter of at least 6 millimeters when the non-compliant balloon is in the inflated state.
 16. The guidewire of claim 15, wherein the ratio of the maximum outer diameter in the inflated state relative to the maximum outer diameter in the deflated state is at least 6:1.
 17. The guidewire of claim 12, wherein the lumen terminates at a distal wall, wherein the navigation sensor is located distal to the distal wall, wherein the sensor wire that extends through the lumen and the distal wall and is coupled to the navigation sensor, wherein the sensor wire is configured to communicate the signal generated by the navigation sensor.
 18. The guidewire of claim 12, wherein the sensor wire is fixably attached to the inner surface of the guidewire shaft using an adhesive.
 19. A guidewire comprising: (a) a guidewire shaft, wherein at least a portion of the guidewire shaft is comprised of metal; (b) a non-compliant balloon arranged at a distal portion of the guidewire shaft, wherein the non-compliant balloon is operable to transition between an unexpanded state in which the non-compliant balloon is configured to pass through an isthmus of a Eustachian tube (ET), and an expanded state in which the non-compliant balloon is configured to dilate the ET, wherein the guidewire is configured to assume a maximum outer diameter of 1 millimeter or less when the non-compliant balloon is in the unexpanded state, wherein the non-compliant balloon has a maximum outer diameter of at least 6 millimeters when the non-compliant balloon is in the expanded state to dilate the ET, wherein the ratio of the maximum outer diameter in the expanded state relative to the maximum outer diameter in the unexpanded state is at least 6:1; (c) a navigation sensor operable to generate a signal corresponding to a location of a distal end of the guidewire within a patient; and (d) a sensor wire operatively coupled with the navigation sensor, wherein the sensor wire is fixably attached to an inner surface of the guidewire shaft within the inflatable element.
 20. The guidewire of claim 19, wherein the non-compliant balloon has a working length of approximately 12 millimeters to approximately 24 millimeters. 